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A.P. Pharma Receives FDA Complete Response Letter For APF530
2013-03-28 08:00:00| dairynetwork Home Page
A.P. Pharma, Inc., a specialty pharmaceutical company, recently announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV).
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FDA approves new multiple sclerosis capsules
2013-03-27 23:45:12| Biotech - Topix.net
The Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults with hard-to-treat forms of the disease.
Tags: multiple
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Merck: FDA reviewing tablet to eliminate allergy
2013-03-27 18:30:45| Biotech - Topix.net
Drugmaker Merck & Co. says federal regulators are reviewing its application to sell a new type of treatment for grass pollen allergy that gradually reduces allergy symptoms over time, rather than just temporarily relieving the sneezing and itching.
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Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet
2013-03-27 13:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. Language: English Contact HTML: MerckMedia:Pam Eisele, (908) 423-5042Tracy Ogden, (267) 305-2301orInvestors:Justin Holko, (908) 423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
license
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Judges Side With FDA in Rejecting Stem Cell Device
2013-03-25 17:15:04| Biotech - Topix.net
A federal appeals court has sided with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used to process adult stem cells.
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